FDA Inspection
James C.-Y Chou, M.D.James C.-Y Chou, M.D. – FDA Inspection, May 22, 2017
Record Details
This FDA Inspection record concerns James C.-Y Chou, M.D., with an inspection on May 22, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3254cb53-1544-4864-9b96-c275916302c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1011841
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.64(b)Safety reports
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Other FDA inspections of James C.-Y Chou, M.D.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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